NCT03119935

Brief Summary

This is a simulation study with a prospective randomized cross-over design. The aim of this study is to evaluate whether Amflow-assisted ambu-bag can delivery the accurate tidal volume compare to ordinary ambu-bag

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

April 14, 2017

Last Update Submit

December 17, 2017

Conditions

Ventilation Therapy; Complications

Keywords

ambu bag, ventilation, tidal volume

Outcome Measures

Primary Outcomes (1)

  • Tidal volume

    We compared mean tidal volume delivered to manikins between two techniques

    6 minutes

Secondary Outcomes (1)

  • Ventilation Rate

    6 minutes

Study Arms (2)

Amflow assist ambu bag ventiation

EXPERIMENTAL

Newely developed method (Amflow assist ambu bag ventilation)

Device: Amflow

Ambu bag ventilation

EXPERIMENTAL

Ordinary method (ambu bag ventilation

Device: Ambu bag

Interventions

AmflowDEVICE

Amflow deviced was developed for monitoring ventiation rate and ventilation volume. Participants ventilated the simulated patients by Amflow-device assist ambu bag

Amflow assist ambu bag ventiation
Ambu bagDEVICE

Participants ventilated the simulated patients by ambu bag

Ambu bag ventilation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A healthy senior medical students who agree attend this study.

You may not qualify if:

  • A participants who does not agree attend this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Emergency Medicine, Konkuk University Medical center

Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sang O Park, Dr

    Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 19, 2017

Study Start

March 1, 2017

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)